PIK3CA mutations play a significant role in various cancers, particularly in hormone receptor-positive, HER2-negative breast cancer, where they occur in about 40% of cases, mainly within Exons 9 and 20. These mutations are also prevalent in endometrial, colon, urinary tract, cervical, and large intestine cancers.

Importance of Detection

Detecting PIK3CA mutations is crucial for personalizing treatment plans. The Qiagen therascreen® PIK3CA RGQ PCR Kit, approved by the FDA and CE-IVD, identifies these mutations in tumor tissue and circulating tumor DNA (cfDNA) with a sensitivity of 12.5% for PIK3CA-11 mutations.

The FDA has approved alpelisib (PIQRAY®) in combination with fulvestrant for postmenopausal women and men with PIK3CA-mutated advanced or metastatic breast cancer. The therascreen® PIK3CA RGQ PCR Kit serves as a companion diagnostic test, ensuring the selection of appropriate candidates for targeted therapies.

Reference Set of Control

The Reference Set of Control designed for the therascreen® PIK3CA RGQ PCR Kit aligns with the assay protocol, enhancing test accuracy and patient outcomes.

Conclusion

PIK3CA mutations are critical in guiding treatment decisions for hormone receptor-positive, HER2-negative breast cancer. Utilizing advanced diagnostic tools like the Qiagen therascreen® PIK3CA RGQ PCR Kit empowers healthcare providers to offer personalized care and improve patient outcomes. Discussing PIK3CA testing with a healthcare provider can significantly impact treatment strategies for those diagnosed with breast cancer.